As feds ponder solutions, bedrails pose deadly hazard to frail, elderly, mentally impaired
10/08/2013 6:00 AM
01/20/2014 7:36 PM
After 81-year-old Clara Marshall badly bruised herself in a tumble from her bed at a care facility in Vancouver, Wash., the staff urged her husband to buy a metal safety rail to protect her from another fall.
The device had only been attached to the side of Marshall’s bed for about five weeks when she rolled over in March 2007 and her neck became stuck in the railing. Marshall, who suffered from dementia, suffocated and died.
Stunned by grief, Marshall’s daughter, Gloria Black, at first assumed her mother’s death was a freak accident.
For years before and after Marshall’s death, thousands of frail, confused or elderly people have been injured and hundreds killed after becoming trapped in safety rails installed to keep them from falling out of bed.
“The underlying belief on the part of everyone was you purchase one of these things and it makes you safer,” Black said. “Well, now I’ve learned otherwise.”
News accounts of such tragedies are infrequent, but a review of articles, court records and incident reports filed with federal or state agencies reveal some victims’ names and the disturbingly similar circumstances of their deaths:
– Hospice patient Harry Griph Sr., 75, died in 2004 with his neck trapped between a mattress and a bedrail at an assisted living facility in Brookfield, Wis.
– Mary Campbell, 82, who had been diagnosed with Alzheimer’s disease, was found suffocated to death, her neck pinned between a bedrail and a mattress in a Kansas City, Mo., nursing home in 1996.
– Ouida Ethridge was 86 in 2009 when she asphyxiated, her head wedged between the side rails and air mattress on her bed at a rehabilitation center in Friendswood, Texas. – In 2011, a nurse at a hospital in Allentown, Pa., found 88-year-old Donald Campbell strangled in bed, with his right shoulder and upper body between the mattress and the side rail. Records show he had been in a “confused state.”
– Nanette Galbraith, an 84-year-old Alzheimer’s patient, died last year after her head became stuck between her hospital bed and a side rail at an adult care home in Wilmington, N.C.
The federal government has long known about the dangers of bedrails but has done little to enforce safety requirements.
“That is amazing to me that you can have a product sold in a medical supply store and no one has verified is this safe,” said Black, who now campaigns for mandatory safety standards for bedrails – or preferably an outright ban.
Nationwide, nearly 37,000 people visited hospital emergency rooms and 155 people died because of injuries caused by adult portable bedrails between 2003 and 2012, according to the Consumer Product Safety Commission. Most of the accidents occurred in private homes, nursing homes or assisted living facilities. More than 80 percent of the victims were over age 60.
The U.S. Food and Drug Administration has received 901 reports of patients who became trapped, entangled or strangled in hospital bedrails since 1985, including 531 fatalities. Most were frail or mentally impaired.
“It’s a horrible, tragic, painful, scary way to die, and it’s just so unnecessary,” said Steve Levin, a Chicago attorney who represents residents of long-term care facilities.Levin believes the number of fatal incidents and near-misses involving adult bedrails is underreported. Elderly victims might not have any family, or even if they do, their relatives may not know where to report the incident. And sometimes bedrail accidents are covered up by care facilities fearful of lawsuits or citations, he said.
In one case Levin worked on, a nursing home hid a bed and mattress after a patient strangled in the rails.
“If an elderly resident dies in bed it would not be difficult for a nursing home to attribute the cause of death to whatever medical conditions brought them to the nursing home,” he said.
Confidentiality clauses inserted into lawsuit settlements also obscure the extent of the problem by silencing families of bedrail victims from sharing their personal stories, Levin said. “That creates a public safety issue,” he said.
Part of the problem is that deaths and injuries in the senior population tend to provoke less public outrage – and fewer calls for regulations or reform – than deaths and injuries of infants, said Robyn Grant, director of public policy and advocacy for National Consumer Voice for Quality Long-Term Care, a national consumer advocacy organization.
“I think there is a societal prejudice – call it ageism – but we focus more on youth and children in our society and not on elders,” Grant said. “It’s important that we focus on children, we need to protect them and keep them safe, but we also need to bring that same attention and concern to elders because many of them are extremely frail and vulnerable and at risk.”
Unlike children’s cribs and bedrails, which must by law meet certain design criteria and pass safety tests, adult bedrails are relatively unregulated.
Steven Miles, a professor of medicine at the University of Minnesota, first identified the trend of adult bedrail accidents about two decades ago, leading the FDA to issue a safety alert for bedrails associated with hospital beds in 1995.
Despite the FDA’s alert, people continued to be injured and die tangled in adult bedrails. So the FDA formed a working group made up of manufacturers, hospitals, health care providers and government officials. The group issued non-legally binding guidance for hospital bedrails in 2006 but decided against requiring warning labels after pushback from industry.
Miles has been waiting for the government to take more meaningful action ever since. “I haven’t started holding my breath,” he said.
The FDA says voluntary guidance is “an efficient regulatory tool,” adding that reports of patient entrapment associated with the use of hospital bed side rails have decreased in recent years. But the agency admits there is a lack of research on the need and purpose of side rails.
“The FDA is concerned that the risk of serious injury to patients from bedrails remains a problem, despite concerted efforts by federal agencies to mitigate hazards,” the agency said in response to written questions.
Some long-term care providers argue that rails can be a helpful tool if used properly, and that banning them completely could increase the risk of falls.
Golden Living, which runs Medicare- and Medicaid-certified nursing and assisted living facilities in 21 states, said in comments posted in the Federal Register that its centers use half-rails or assist rails in tandem with alternating pressure mattresses to reduce ulcers.
Candace Bartlett, Golden Living’s senior director of regulatory affairs, wrote in the comments that while caretakers must adhere to manufacturer guidelines, the government should “avoid rulemaking which would eliminate their use altogether.”
Recently, pressure from Black, consumer groups and members of Congress have refocused the government on the need for closer scrutiny of adult bedrails, especially a portable version intended for use with an ordinary home-style bed, rather than a hospital bed. Since portable bedrails typically aren’t considered medical devices, the FDA guidelines for hospital bedrails don’t apply to them.
Yet portable rails are particularly dangerous, said the University of Minnesota’s Miles.
Consumers can get easily confused about how to install the devices safely, while staff at nursing homes and long-term care facilities sometimes mix and match them with mattresses that don’t fit or that compress easily, leaving a gap for the patient to fall into, Miles said.
“You wind up with these ad-hoc systems that really don’t work very well,” he said.
In April and May, consumer groups and patient advocates filed petitions with the federal government asking for a ban on adult portable bedrails as “hazardous products” or for mandatory standards.
The next month, the Consumer Product Safety Commission joined with the FDA to announce that the two agencies would work together to address bedrail safety with ASTM International, a nonprofit company that develops voluntary standards for more than 100 different industry sectors, from steel to plastics.
The committee assigned to write the voluntary standards for adult portable bedrails has about 70 participants, including consumer advocates, government officials, manufacturers and test labs, said Len Morrissey, director of technical committee operations for ASTM.
Morrissey doesn’t expect an official draft of voluntary standards to be ready before the end of October at the earliest, and a final version realistically won’t be ready for at least another year.
Voluntary standards fall short of petitioners’ demands, but CPSC spokesman Scott Wolfson said the commission is empowered under the law to take mandatory action only if voluntary standards fall short or don’t bring down the number of deaths and injuries.
“The environment right now is not moving in direction of a ban,” Wolfson said. “It’s about establishing performance standards that will make these products safer. . . . If the ASTM process does not work out in a positive way for consumers, then we could step in.”
Black, who serves on the ASTM committee, is frustrated with the slow process, especially given how long it has taken just to get to this point.
“It’s really too bad how many more people will die this year in bedrails while we are waiting for the standards process to get moving,” she said.
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